Cobicistat-containing Highly Active Antiretroviral Regimens in HIV-1 Infected Patients With Mild to Moderate Renal Impairment

PHASE3CompletedINTERVENTIONAL
Enrollment

106

Participants

Timeline

Start Date

May 31, 2011

Primary Completion Date

January 31, 2013

Study Completion Date

February 28, 2015

Conditions
Acquired Immunodeficiency SyndromeHIV Infections
Interventions
DRUG

E/C/F/TDF

E/C/F/TDF (150/150/200/300 mg) STR administered orally once daily

DRUG

COBI

COBI 150 mg tablet administered with food orally once daily

DRUG

ATV

ATV 300 mg tablet administered orally once daily

DRUG

DRV

DRV 800 mg tablet administered orally once daily

DRUG

NRTI

Participants will receive 2 investigator-selected NRTIs, which may include abacavir (ABC), lamivudine (3TC)/zidovudine (ZDV), didanosine (DDI), emtricitabine (FTC), ABC/3TC, 3TC, tenofovir disoproxil fumarate (TDF), or FTC/TDF, administered according to prescribing information.

Trial Locations (51)

1140

Otto Wagner Spital, Vienna

2010

Taylor Square Private Clinic, Darlinghurst

Holdsworth House Medical Practice, Sydney

3004

Infectious Diseases Unit - The Alfred Hospital, Melbourne

8020

Landeskrankenhaus Graz West, Graz

10011

Chelsea Village Medical, New York

Mount Sinai Downtown Comprehensive Health Program, New York

11030

North Shore University Hospital, Manhasset

14607

AIDS Care, Rochester

20009

Whitman Walker Clinic, Washington D.C.

20037

Medical Faculty Associates, Washington D.C.

28207

Carolinas Medical Center, Charlotte

30033

Infectious Disease Specialists of Atlanta, Decatur

31201

Mercer University/ Mercer Medicine Clinical Research, Macon

32803

Orlando Immunology Center, Orlando

32806

IDOCF/ValueHealthMD, LLC, Orlando

33308

Therafirst Medical Center, Fort Lauderdale

33311

Broward Health, Fort Lauderdale

33316

Gary J. Richmond.M.D.,P.A., Fort Lauderdale

34982

Midway Immunology and Research Center, Ft. Pierce

40237

Center for HIV and Hepatogastroenterology, Düsseldorf

44280

"Hospital Civil de Guadalajara Fray Antonio Alcalde", Guadalajara

60657

Northstar Medical Center, Chicago

63108

Central West Clinical Research, Inc., St Louis

72207

Health for Life Clinic, Little Rock

75001

Southwest Infectious Disease Clinical Research, Inc., Addison

76104

Tarrant County Infectious Disease Associates, Fort Worth

77004

Therapeutic Concepts, PA, Houston

80206

National Jewish Health, Denver

85012

Spectrum Medical Group, Phoenix

90027

Kaiser Permanente, Los Angeles

90036

Peter J. Ruane, M.D., Inc., Los Angeles

90069

Anthony Mills, MD, Inc., Los Angeles

90211

AHF Research Center, Beverly Hills

92663

Orange Coast Medical Group, Newport Beach

94115

Metropolis Medical, San Francisco

94609

East Bay AIDS Center, Oakland

99999

Instituto Dominicano de Estudio Virologicos, Santo Domingo

01105

University of California, Davis, Sacramento

The Research Institute, Springfield

06520

Yale University School of Medicine AIDS Program, New Haven

08844

ID Care, Hillsborough

M4N3M5

Sunnybrook Health Sciences Center, Toronto

H2L5B1

Clinique Medicale du Quartier Latin, Montreal

00909

Clinical Research Puerto Rico, San Juan

HOPE Clinical Research, San Juan

BN2 1ES

Brighton and Sussex University Hospitals NHS Trust, Brighton

E1 1BB

Barts & the London NHS Trust, London

SE5 0DJ

Homerton University Hospital, London

SE5 9RJ

Guy's King's and St. Thomas' School of Medicine, London

SW10 9NH

St Stephen's AIDS Trust, London

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY